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罗氏药厂宣布其依米珠单抗(emicizumab)治疗有凝血因子Ⅷ(FⅧ)抑制剂的A型血友病患者的Ⅲ期临床试验达到主终点,用药组一段时间内出血次数明显少于非用药组。最常见副作用是注射部位反应。该药是双特性单克隆抗体,含有激活自然凝血过程需要的凝血因子Ⅸ(FⅨ)和Ⅹ(FⅩ)蛋白。每周皮下注射1次。Ⅲ期临床HAVEN 1试验是随机、多中心、开放研究,评价用该药预防组与无药预防组的药效学、疗效及安全性。共入选109名≥12岁曾按需或预防性使用过旁路作用药物的A型血友病(有FⅧ抑制剂)患者。患
Roche announced that its phase III clinical trial of emicizumab in patients with hemophilia A treated with inhibitors of factor VIII (FⅧ) reached the primary endpoint with significantly less bleeding over time group. The most common side effect is injection site reaction. This drug is a bimodal monoclonal antibody that contains the coagulation factor Ⅸ (FIX) and Ⅹ (Ⅹ) proteins required to activate the native clotting process. Subcutaneous injection once a week. The Phase III HAVEN 1 trial was a randomized, multicenter and open study to evaluate the pharmacodynamics, efficacy and safety of the prophylactic and non-prophylactic groups. A total of 109 patients with type A hemophilia (with FⅧ inhibitor) who were on-demand or prophylactic use of a bypass agent ≥12 years of age were enrolled. Suffering